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The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus. WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.

This document is a 510(k) summary for the Interpore Cross Cement Restrictor. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically focuses on demonstrating substantial equivalence rather than presenting performance data against set acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document. The document primarily focuses on:

• Device Description: The Interpore Cross CEMENT RESTRICTOR is a resorbable implant made from a polymer-ceramic composite, designed to wedge into the medullary canal to prevent cement flow and allow for pressurized filling during joint arthroplasty.
• Indications-For-Use: As a cement restrictor in the femur, tibia, and/or humerus.
• Predicate Device: Interpore Cross Cement Restrictor (suggesting it's an update or new version of an existing product).
• Substantial Equivalence: Claimed to be substantially equivalent to the cited predicate devices based on indications for use, design features, principles of operation, and materials.
• FDA Communication: The FDA letter confirms the substantial equivalence determination but adds a WARNING: "THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED." This indicates a specific limitation on the device's use due to a lack of established safety and effectiveness in that particular application.

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The Interpore Cross CEMENT RESTRICTOR is intended for use as a cement restrictor in the femur, tibia and/or humerus.

The Interpore Cross CEMENT RESTRICTOR is a resorbable implant manufactured from a polymer-ceramic composite. The Interpore Cross CEMENT RESTRICTOR is designed to wedge into the medullary canal during joint arthroplasty to prevent flow of cement into the canal and allow for pressurized filling of the implantation site. It is provided in various shapes and sizes as needed for particular surgical procedures.

The provided document is a 510(k) summary for the Interpore Cross CEMENT RESTRICTOR. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results for the device itself.

Based on the provided text, there is no detailed study described that proves the device meets specific acceptance criteria in terms of performance metrics. The submission argues for substantial equivalence based on indications for use, design features, principles of operation, and materials compared to already marketed predicate devices.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) cannot be answered.

Here's what can be extracted from the document in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. The implicit "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" is described qualitatively by stating it functions similarly to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document explicitly states it is a 510(k) summary demonstrating substantial equivalence, not a performance study. Therefore, there is no "test set" or associated data described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical cement restrictor, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No specific ground truth for performance evaluation is mentioned. The "ground truth" for the 510(k) substantial equivalence determination is the established understanding and performance of the predicate devices.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device.

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